Nutritional intervention composition for enhancing and extending satiety

ABSTRACT

This invention relates to a nutritional intervention composition in a dry power form for enhancing satiety prior to a meal and extending satiety after a meal in a calorically efficient fashion. The dry nutritional composition includes protein, caseinmacropeptides (CMP) or glycomacropeptides (GMP) or any hydrolysis product of GMP, long chain fatty acids, soluble and/or insoluble fibers. The dry nutritional composition includes protein in the range of 0.21% to 88.30%, glycomacropeptide in the range of 0.05% to 87.72%, oleic acid in the range of 2.27% to 97.25%, soluble fibers in the range of 0.19% to 79.05%, and insoluble fibers in the range of 0.19% to 79.05%. The composition may also include plant saponins, calcium and cholestyramine.

RELATED APPLICATIONS

[0001] This application is a continuation in part of application Ser.No. 09/510,809 filed on Feb. 23, 2000.

FIELD OF THE INVENTION

[0002] The present invention relates to a nutritional interventioncomposition for enhancing satiety prior to the consumption of a mealresulting in reduced caloric intake during the meal, and lengthening theinter-meal interval by extending satiety for up to three and a halfhours following the meal. More particularly, the nutritionalintervention composition includes a protein source, caseinmacropeptidesor glycomacropeptides or any hydrolysis product of GMP, long chain fattyacids and soluble and/or insoluble fibers. By extending the feeling ofsatiety, the nutritional intervention composition decreases food intakeproducing weight loss over time. The composition can be taken prior to ameal or can be mixed with food to extend the satiation effect of thatfood.

[0003] The present invention also relates to a nutritional interventioncomposition to help individuals with Type II diabetes maintain glycemiccontrol and extend satiety. By extending the feeling of satiety, thenutritional intervention composition decreases food intake resulting ina decrease in body weight over time while providing better regulation ofglucose and insulin levels following consumption of a meal. Furthermore,since CCK causes a delay in stomach emptying, the nutritionalintervention composition can slow the absorption of glucose by the smallintestine further improving glycemic control.

[0004] The present invention also relates to a nutritional interventioncomposition designed as an adjunct to treat patients with bulimia andeating disorders who have been shown to have a defect in their satietycontrol mechanisms. By stimulating satiety before a meal and extendingsatiety after a meal, the present invention reduces binge eating inbulimic patients.

BACKGROUND OF THE INVENTION

[0005] Satiety

[0006] Cholecystokinin (CCK) is a peptide released following theconsumption of food. The literature demonstrates an injection of CCK inanimals elicited the total range of satiety behavior.

[0007] Release of cholecystokinin has also been shown to be a satietysignal in humans. In 1981, researchers showed that an injection of CCKdecreased food intake by 16 percent. The subjects did not alter theirrate of eating but rather stopped eating earlier, which would be theexpected results if cholecystokinin were a satiety signal. The resultsin humans confirmed the results in the laboratory that CCK is animportant agent in terminating the meal. Although the full mechanismwhereby CCK exerts its effect on satiety is not known, there appears tobe two components, a central component involving CCK receptors in thebrain and a peripheral component involving the stomach and smallintestines.

[0008] When food is consumed, CCK releasing protein (CCKRP) is releasedin the small intestine. CCKRP stimulates CCK release from intestinalcells. The release of CCK generates the behavioral symptoms associatedwith satiety and at the same time activates a number of negativefeedback mechanisms to turn off the CCK response. There are primarilytwo negative feedback mechanisms, one involving proteases secreted bythe pancreas and the second bile from the gallbladder. CCK stimulatesthe pancreas to secrete a number of proteases, specifically trypsin andchymotrypsin, which inactivate CCKRP. CCK also stimulates gallbladdercontraction causing bile acids to be released into the intestinal lumen.Bile acids are powerful regulators of CCK, inhibiting its release.

[0009] The literature has also shown that CCK release can be stimulatedby protein such as whey and casein, hydrolysis products of caseinincluding glycomacropeptide, phenylalanine, calcium and long chain fattyacids. All of the literature to date has shown that regardless of howCCK is stimulated or what intervention is taken to prevent itsbreakdown, its reported effect is on the termination of the meal.

[0010] It has been well documented that some soluble and insolublefibers as well as plant saponins bind bile salts. In fact, it is thebinding of bile salts by fiber, which is believed partly responsible forthe hypocholestrolemic effect of these agents. Different fibers havedifferent binding capacities to the various bile salts. For instance,cellulose has been shown to bind bile acids poorly.

[0011] The ability of CCK to reduce appetite would appear to make it anextremely useful agent in treating obesity. In a weight managementprogram, stimulation of CCK would result in less food consumed andreduction of hunger cravings between meals. These effects would enablean overweight individual to better comply with a diet that has a reducedcaloric intake. The major limitation in the use of CCK, as an appetitecontrol agent, is that it must be given by injection. Additionally, CCKrelease initiates a number of negative feedback mechanisms describedabove involving the pancreas and gallbladder that terminate the CCKresponse.

[0012] There is a definite need in the art for a nutritionalintervention composition that can be taken orally to permit a subject tobe satiated with a lower caloric intake. There is also a definite needin the art for a nutritional intervention composition that not only canbe taken prior to a meal to stimulate satiety before the meal but whoseproperties extend satiety following the meal thereby lengthening theinter-meal interval.

[0013] There is also a definite need in the art for a nutritionalintervention composition that can be taken orally and that with a totalcaloric value of only 80 calories can strongly provoke satiety.

[0014] Glycemic Control

[0015] It is well known the art that slowing gastric emptying can bluntthe post-prandial rise in glucose and insulin. Most persons with Type IIdiabetes are obese and have an inability to respond normally to insulin.Obesity is a major contributing factor to the development of Type IIdiabetes. The primary treatment for Type II diabetics is diet and aweight loss program. Dietary guidelines for Type II diabetics includeconsumption of fiber. Fiber has been shown to slow gastric emptying. Oneof the prominent effects of cholecystokinin is also to delay gastricemptying. The ability of fiber and cholecystokinin to delay gastricemptying are well known in the art and the result of delayed gastricemptying is to slow the absorption of glucose.

[0016] There is a definite need in the art for a nutritionalintervention composition that can be taken orally by Type II diabeticsthat stimulates the release of CCK in a calorically efficient way, andthat permits Type II diabetics to be satiated with a lower caloricintake and offers a better degree of glycemic control.

[0017] There is a definite need in the art for a nutritionalintervention composition that not only can be taken prior to a meal tostimulate satiety before the meal but whose properties extend satietyfollowing the meal thereby lengthening the intermeal interval in orderto help the Type II diabetic lose weight.

[0018] Bulimia

[0019] Bulimia is an eating disorder that usually effects females. Amajor characteristic of bulimia is an inability to become satiated byfood. As a result bulimics tend to binge on food and regurgitate it toprevent weight gain. This disorder is classically treated withpsychotherapy. Studies have shown that bulimics have a defect in theirnormal satiety mechanisms. They release less CCK following a meal.

[0020] There is a definite need in the art for a nutritionalintervention composition that can be taken orally by bulimics, and is acalorically efficient stimulator of CCK to permit bulimics to besatiated. An important element of this invention is the design of aproduct that not only can be taken prior to a meal to stimulate satietybefore the meal but whose properties extend satiety following the mealthereby lengthening the inter-meal interval.

DESCRIPTION OF THE PRIOR ART

[0021] Satiety

[0022] U.S. Pat. No. 4,833,128 discloses the oral administration ofphenylalanine in conjunction with protein, carbohydrate and fat tostimulate satiety. This invention teaches that when a dietary supplementcontaining phenylalanine is consumed fifteen minutes prior to a meal, itgenerates a feeling of satiety resulting in less food consumption at thesubsequent meal. The CCK release slows gastric emptying and the fiber inthe invention provides an additional effect by slowing gastric emptying.The nutritional supplement in this patent contains 140 calories and itis recommended that it be taken three times a day. At a dose of threetimes a day this dietary supplement would provide almost 25% of thetotal calories suggested in a reduced caloric program (1600 calories) tolose weight. Furthermore, the addition of phenylalanine limits its usein patients with phenylketonuria. The invention also teaches thatcellulose should be added. Cellulose has been shown to be one of thepoorest binders of bile acids and therefore would not stimulate satietyby blocking the effect of bile acids and salts on cholecystokininrelease. Finally, the invention does not have any effect on extendingthe duration of action of CCK. In fact, the invention teaches that theappetite suppression of CCK may be merely temporary resulting in alimited satiety effect.

[0023] U.S. Pat. No. 4,491,578 discloses the oral administration of atrypsin inhibitor to enhance satiety by stimulating the release of CCK.This patent teaches that the negative feedback signal forcholecystokinin secretion results from the release of trypsin from thepancreas. The administration of a therapeutically effective quantity oftrypsin inhibitor blocks the trypsin released from the pancreas therebyinterfering with a negative feedback mechanism. The nutritionalintervention composition described in this application does not dependon trypsin inhibition for its effect on satiety.

[0024] U.S. Pat. No. 5,932,561 teaches that dietary supplements thatbind lipids can aid in weight loss and reduce cholesterol. The patentalso teaches that a dietary supplement composition that containssaponins from aloe increase the capacity of chitosan to bind fat. Thesaponins also act as a laxative to off set the constipating effects ofchitosan. This patent does not teach that either chitosan or saponinscan be used to stimulate cholecystokinin. The weight managementcharacteristics of this invention are to primarily combine fat andcholesterol and remove it from the body.

[0025] U.S. Pat. No. 5,703,052 teaches that saponins are useful incontrolling hypercholesterolemia. This patent does not describe the useof saponins as a stimulator of CCK.

[0026] Glycemic Control

[0027] U.S. Pat. No. 5,187,154 teaches that Type II diabetics exhibitmore rapid gastric emptying than normal controls in the early stages oftheir diagnosis and that an invention that can slow gastric emptyingwill improve glycemic control. The patent also teaches that theinvention is useful for assessing the risk of diabetes in subjects whodo not show any abnormalities in glucose metabolism. The patent utilizesa therapeutic dose of trypsin inhibitor to stimulate CCK release andthereby slow gastric emptying which in turn results in improved glycemiccontrol. The nutritional intervention described in the present inventiondoes not depend on trypsin inhibition for its effect on glycemiccontrol.

[0028] None of the prior art patents disclose the nutritionalcomposition of the present invention for enhancing and extending satietywith a calorically efficient preparation.

OBJECTS

[0029] Accordingly it is an object of the present invention to provide anutrition intervention composition for enhancing satiety before a meal.

[0030] Another object of the present invention is to provide a nutritionintervention composition to extend satiety after a meal.

[0031] Another object of the present invention is to provide a nutritionintervention composition that can be consumed prior to a meal to enhancesatiety.

[0032] Another object of the present invention is to provide a nutritionintervention composition that can be added to food to extend thesatiating effect of the food to which it is added.

[0033] Another object of the present invention is to provide a nutritionintervention composition to stimulate cholecystokinin release in acalorically efficient manner.

[0034] Another object of the present invention is to provide a nutritionintervention composition to increase cholecystokinin by stimulating itsrelease through a combination of nutritional agents.

[0035] Another object of the present invention is to provide a nutritionintervention composition to stimulate cholecystokinin release by bindingto bile salts.

[0036] Another object of the present invention is to provide a nutritionintervention composition to cause weight loss resulting from a reducedcaloric intake.

[0037] Another object of the present invention is to provide a nutritionintervention composition to provide better glycemic control for Type IIdiabetics.

[0038] Another object of the present invention is to provide a nutritionintervention composition to help Type II diabetics enhance and extendsatiety in a calorically efficient fashion.

[0039] Another object of the present invention is to provide a nutritionintervention composition to increase satiety in bulimics who have adefect in their normal CCK release mechanism.

[0040] Another object of the present invention is to provide a nutritionintervention composition to help in the management of the bulimicpatients.

[0041] Another object of the present invention is to provide a nutritionintervention composition that is palatable, well tolerated and withoutside effects to individuals.

SUMMARY OF THE INVENTION

[0042] In brief this invention relates to a nutritional interventioncomposition in a dry power form for enhancing satiety prior to a mealand extending satiety after a meal in a calorically efficient fashion.The dry nutritional composition includes protein, caseinmacropeptides(CMP) or glycomacropeptides (GMP) or any hydrolysis product of GMP, longchain fatty acids, soluble and/or insoluble fibers. The dry nutritionalcomposition includes protein in the range of 0.21% to 88.30%,glycomacropeptide in the range of 0.05% to 87.72%, oleic acid in therange of 2.27% to 97.25%, soluble fibers in the range of 0.19% to79.05%, and insoluble fibers in the range of 0.19% to 79.05%. Thecomposition may also include plant saponins, calcium and cholestyramine.

BRIEF DESCRIPTION OF THE DRAWINGS

[0043] Further objects, features, and advantages of the presentinvention will become apparent upon the consideration of the followingdetailed description of the presently preferred embodiment when taken inconjunction with the accompanying drawings, wherein:

[0044]FIG. 1 is a graph showing a comparison of hunger ratings between aplacebo group and the nutritional intervention composition of thepresent invention.

[0045]FIG. 2 is a graph showing a comparison of food consumption ratingsbetween a placebo group and the nutritional intervention composition ofthe present invention.

[0046]FIG. 3 is a graph showing a comparison of hunger ratings followingconsumption of two forms of low fat yogurt, one containing a placebomixture and the other containing the nutritional interventioncomposition of the present invention.

[0047]FIG. 4 is a graph showing a comparison of the change in hungerratings over time following consumption of two forms of low fat yogurt,one containing a placebo mixture and the other containing thenutritional intervention composition of the present invention.

[0048]FIG. 5 is a graph showing a comparison of food consumption ratingsfollowing consumption of two forms of low fat yogurt, one containing aplacebo mixture and the other containing the nutritional interventioncomposition of the present invention.

[0049]FIG. 6 is a graph showing the effect of the nutritionalintervention composition on appetite change over six weeks.

[0050]FIG. 7 is a graph showing the effect of the nutritionalintervention composition on food cravings over six weeks.

[0051]FIG. 8 is a graph showing the effect of the nutritionalintervention composition on appetite over six weeks.

[0052]FIG. 9 is a graph showing the effect of the nutritionalintervention composition on weight loss over six weeks.

[0053]FIG. 10 is a table showing the effect of the nutritionalintervention composition on mean satiety ratings over six weeks.

DETAILED DESCRIPTION OF THE INVENTION

[0054] The invention is based on the unexpected and surprising discoverythat by providing a nutritional intervention composition to stimulateCCK release and block the negative feedback mechanisms that inhibit CCKrelease, satiety is enhanced with the consumption of fewer calories andsatiation effects can be extended for up to three and one half hoursfollowing the meal.

[0055] A second unexpected and surprising discovery is that by consumingas little as 80 calories of the nutritional composition, one can producea significant and extended satiation effect with the consumption of ameal of only 385 calories.

[0056] A third unexpected and surprising discovery is that by combiningspecific soluble and/or insoluble fibers with plant saponins one canbind specific bile salts thereby removing powerful inhibitors ofcholecystokinin release.

[0057] A fourth unexpected and surprising discovery is that by consumingglycomacropeptides (GMP) or caseinmacropeptides (CMP) one can enhancesatiety.

[0058] The nutritional intervention composition of the inventioncomprises caseinmacropeptides (CMP) or glycomacropeptides (GMP) or anyhydrolysis product of GMP, long chain fatty acids C₁₂ to C₁₈ in length,and soluble and/or insoluble fibers. The composition may further includeprotein, calcium and/or plant saponins. The nutritional interventioncomposition can be taken ten to fifteen minutes before a meal, during ameal or incorporated into food to produce an extended effect onsatiation.

[0059] The nutritional intervention composition is designed to achievemultiple effects leading to the increase in satiety by stimulating andmaintaining levels of CCK. According to the present invention,stimulation of CCK by meals not only produces satiety but alsostimulates negative feedback mechanisms, involving the gall bladder'srelease of bile salts which inhibit CCK release, resulting in a decreasein satiety. An important aspect of the invention is that a combinationof elements are used to stimulate CCK and at the same time reduce thelevel of bile salts in the intestine so that CCK release is notinhibited.

[0060] In one of the preferred embodiments, the source of protein iscasein, whey or soy. The preferred range for the protein is in the rangeof 1.0 to 4.0 grams by weight of the composition, or in the range of3.52% to 44.97% by weight of the composition. The broad range for theprotein is in the range of 0.10 to 10.0 grams by weight of thecomposition, or in the range of 0.21% to 88.30% by weight of thecomposition.

[0061] In the preferred embodiment, the source of caseinmacropeptides(CMP) or glycomacropeptides (GMP) or any hydrolysis product of GMP iswhey protein concentrate. Glycomacropeptide (GMP) is the glyosilatedform of caseinmacropeptide (CMP), the first hydrolysis product resultingfrom the action of gastric proteases on kappa casein. The preferredrange for CMP, GMP or any hydrolysis product of GMP is in the range of0.03 to 1.0 grams by weight of the composition, or in the range of 0.10%to 14.57% by weight of the composition. The broad range for the CMP, GMPor any hydrolysis product of GMP is in the range of 0.025 to 10.0 gramsby weight of the composition, or in the range of 0.05% to 87.72% byweight of the composition.

[0062] The most effective fatty acids in stimulating CCK are long chainfatty acids between C₁₂ to C₁₈ in length. In the preferred embodiment,C₁₈ oleic acid is used. Sources of oleic acid are babassu oil, butteroil, chicken fat, cocoa butter, coconut oil, corn oil, cottonseed oil,lard, olive oil, palm oil, palm kernel oil, peanut oil, rapeseed oil,safflower oil, soybean oil, sunflower oil, tallow or tucum oil. Thepreferred range for the long chain fatty acids are in the range of 2.0to 9.0 grams by weight of the composition, or in the range of 8.20% to69.79% by weight of the composition. The broad range for the long chainfatty acids are in the range of 1.0 to 15.00 grams by weight of thecomposition, or in the range of 2.27% to 97.25% by weight of thecomposition. The preferred range for oleic acid is in the range of 1.0to 4.0 grams by weight of the composition, or in the range of 3.52% to44.97% by weight of the composition.

[0063] The source of the soluble fibers are guar, glucomannan, potato,methyl cellulose, phyllium, pectin, oat fiber and sugar beet. The sourceof the insoluble fibers are cellulose, potato, lignin, hemicelluloses,and insoluble pectins. The preferred range for the soluble and/orinsoluble fibers are in the range of 1.5 to 7.0 grams by weight of thecomposition, or in the range of 5.79% to 61.40% by weight of thecomposition. The broad range for the soluble and/or insoluble fibers arein the range of 0.20 to 10.0 grams by weight of the composition, or inthe range of 0.41% to 89.09% by weight of the composition. The preferredrange for the soluble fibers are in the range of 1.0 to 4.0 grams byweight of the composition, or in the range of 3.52% to 44.97% by weightof the composition. The broad range for the soluble fibers are in therange of 0.10 to 5.0 grams by weight of the composition, or in the rangeof 0.19% to 79.05% by weight of the composition. The preferred range forthe insoluble fibers are in the range of 0.50 to 3.0 grams by weight ofthe composition, or in the range of 1.75% to 35.74% by weight of thecomposition. The broad range for the insoluble fibers are in the rangeof 0.10 to 5.0 grams by weight by the composition, or in the range of0.19% to 79.05% by weight of the composition.

[0064] The soluble fibers, as well as the insoluble fibers, bind thosespecific bile salts in the intestinal lumen which are the strongestinhibitors of CCK release. At least one soluble fiber, or at least oneinsoluble fiber, or a mixture thereof, may be used in the compositionfor the release of CCK.

[0065] CMP, GMP or any hydrolysis product of GMP have been shown to bemore calorically efficient in stimulating CCK release than protein. Inaddition, CMP, GMP or any hydrolysis product of GMP may also effect thepancreatic feedback mechanism by serving as a substrate source for thereleased proteases. This may lower the amount of available proteases toinactivate CCKRP.

[0066] The composition of the present invention may also includecalcium. Calcium has been shown to stimulate CCK release. The source ofthe calcium may be calcium salts selected from the group consisting ofcalcium carbonate, calcium lactate, calcium citrate, calcium malate andequivalents thereof. The range of calcium is 0.05 to 3.00 grams byweight of the composition.

[0067] The composition may also include plant saponins. The source maybe alfalfa. The range of plant saponins is 0.05 to 10.0 grams by weightof the composition.

[0068] The composition may also include bile acid sequestering resins,such as cholestyramine in the range of 0.10 to 5.0 grams by weight ofthe composition.

[0069] One specific example of the composition of the present inventionis 0.50 grams of GMP, 2.40 grams of oleic acid, and 3.06 grams of guaror glucomannan (soluble fibers).

[0070] Another specific example of the composition is 0.50 grams of GMP,2.40 grams of oleic acid, 3.06 grams of guar or glucomannan, and 2.81grams of whey protein. Another specific example of the composition is0.50 grams of GMP, 2.40 grams of oleic acid, 3.06 grams of guar orglucomannan, 2.81 grams of whey protein, and 0.19 grams of calciumlactate. It is intended that GMP as used herein includes CMP, GMP, orany hydrolysis product of GMP.

[0071] The present invention provides for a nutritional interventioncomposition in a dry powder form for enhancing satiety before a meal andextending satiety following a meal. It is therefore useful in treatmentof weight loss.

[0072] The following charts show additional examples of the presentinvention and caloric contents of different examples: EXAMPLE ONE Range(gm) Percent Ingredient Source grams % Lower Upper Lower Upper ProteinCasein, whey, 2.81 24.67% 1.00 4.00 3.52% 44.97% soy GMP Whey Protein0.50 4.39% 0.03 1.00 0.10% 14.57% Oleic acid Sunflower Oil 2.40 21.07%2.00 9.00 8.20% 69.79% Soluble Fiber Guar, potato, 1.92 16.86% 1.00 4.003.52% 44.97% glucomannan, methyl cellulose Insoluble Fiber Cellulose,1.14 10.01% 0.50 3.00 1.75% 35.74% potato Calcium Lactate, 0.19 1.67%0.05 3.00 0.18% 33.92% Carbonate, Citrate, Malate Flavors 2.20 19.32%1.10 3.00 3.73% 34.11% Emulsifiers Lecithin 0.20 1.76% 0.20 0.40 0.65%6.56% Sweeteners Aspartame, 0.03 0.25% 0.015 4.00 0.05% 40.49% SucroloseTotals 11.39 100.00% 5.895 31.40 Total Soluble 1.50 7.00 5.79% 61.40%and/or Insoluble Fibers

[0073] EXAMPLE TWO Range (gm) Percent Ingredient Source grams % LowerUpper Lower Upper Protein Casein, whey, 2.81 31.02% 0.10 10.00 0.21%88.30% soy GMP Whey Protein 0.50 5.52% 0.025 10.00 0.05% 87.72% Oleicacid Sunflower Oil 2.40 26.49% 1.00 15.00 2.27% 97.25% Soluble FiberGuar, potato, 1.92 21.19% 0.10 5.00 0.19% 79.05% glucomannan, methylcellulose Insoluble Cellulose, 1.14 12.58% 0.10 5.00 0.19% 79.05% Fiberpotato Calcium Lactate, 0.19 2.10% 0.05 3.00 0.09% 68.57% Carbonate,Citrate, Malate Plant Alfalfa 0.10 1.10% 0.05 10.00 0.10% 87.91%Saponins Totals 9.06 100.00% 1.425 58.00 Total Soluble 0.20 10.00 0.41%89.09% and/or Insoluble Fibers

[0074] EXAMPLE THREE Range (gm) Percent Ingredient Source grams % LowerUpper Lower Upper GMP Whey Protein 0.50 8.39% 0.025 10.00 0.18% 89.29%Oleic acid Sunflower Oil 2.40 40.27% 1.00 4.00 4.76% 94.67% SolubleFiber Guar, 1.92 32.21% 0.10 5.00 0.52% 81.63% glucomannan, methylcellulose Insoluble Cellulose, 1.14 19.13% 0.10 5.00 0.52% 81.63% Fiberpotato Totals 5.96 100.00 1.225 24.00 Total Soluble 0.20 10.00 1.41%90.70% and/or Insoluble Fibers

[0075] TABLE ONE CALORIC CONTENT gms gms Cals Cals Item Lower UpperCals/gm Lower Upper Protein 1.00 4.00 4.0 4.00 16.00 GMP 0.03 1.00 4.00.12 4.00 Oleic Acid 3.00 9.00 9.0 27.00 81.00 Soluble or 1.50 7.00 0 00 Insoluble Fibers Total 5.53 21.00 31.12 101.00

[0076] TABLE TWO CALORIC CONTENT gms gms Cals Cals Item Lower UpperCals/gm Lower Upper Protein 0.10 10.0 4.0 0.40 40.00 GMP 0.025 10.0 4.00.10 40.00 Oleic Acid 1.05 15.0 9.0 9.45 135.00 Soluble or 0.20 10.00 00 0 Insoluble Fibers Total 1.425 45.15 9.95 215.00

[0077] TABLE THREE CALORIC CONTENT gms gms Cals Cals Item Lower UpperCals/gm Lower Upper GMP 0.025 10.00 4.0 0.10 40.00 Oleic Acid 1.05 15.009.0 9.45 135.00 Soluble or 0.20 10.00 0 0 0 Insoluble Fibers Total 1.32535.15 9.55 175.00

[0078] The nutritional intervention composition includes a flavorcomponent for imparting a characteristic taste to the nutritionalintervention composition selected from the group consisting of watersoluble, natural or artificial extracts that include apple, banana,cherry, cinnamon, cranberry, grape, honeydew, honey, kiwi, lemon, lime,orange, peach, peppermint, pineapple, raspberry tangerine, watermelon,wild cherry and equivalents thereof; being in the range of 1.10 to 3.00grams by weight of the composition.

[0079] The nutritional intervention composition may include artificialsweeteners such as sucrolose, aspartame, saccharine, acesulfame K, ornatural sweeteners.

[0080] The nutritional intervention composition may be used as a foodadditive added to foods selected from the group consisting of yogurt,jello, apple sauce, cottage cheese, cereal, bread, and candy bars.

[0081] The nutritional intervention composition maybe used as a foodadditive added to drinks selected from the group consisting of applejuice, orange juice, grape juice, grapefruit juice, cranberry juice,coffee, tea, milk, milkshakes, broth, and soup consomme

[0082] Experiment One-Consumption of the Nutritional InterventionComposition of the Present Invention Prior to a Meal

[0083] Ten normal weight subjects (Body Mass Index=24) were administeredeither a placebo containing polydextrose or one containing thenutritional intervention composition of the present invention. Both theplacebo and the nutritional intervention composition of the presentinvention were mixed with 8 oz of water. Both drinks contain 80calories. Following consumption of either drink subjects consumed a mealconsisting of 350 g (385 cal) of Stouffers macaroni and beef casserole.Two satiety tests were performed. On one occasion subjects drank 8 oz ofthe beverage containing the nutritional intervention composition of thepresent invention and the placebo beverage on the other occasion.Subjects were permitted fifteen minutes to consume their meal. Subjectsrated hunger and other questions using a computer before and afterdrinking the beverage, before and after eating the meal and everyfifteen minutes for three and one half hours after the meal. A two wayrepeated measure analysis of variance was used to evaluate the effect ofthe nutritional intervention composition of the present invention. Thesubjects were asked to give their ratings to the following questions:

[0084] 1. How hungry do you feel right now?

[0085] 2. How thirsty do you feel right now?

[0086] 3. How much food would you like to eat right now?

[0087] The results showed there was no difference between the groupswith regards to thirst but there was significant difference (p<0.05)with regard to hunger and how much food the subjects felt they couldeat. At two hours there was a significant difference in hunger ratingsand this difference continued to the end of the experiment. Similarresults were seen in response to subjects' subjective ratings to thequestion, how much food could they eat.

[0088] Experiment Two-Addition of the Nutritional InterventionComposition of the Present Invention to Food

[0089] Ten normal weight subjects (Body Mass Index=24) were administeredeither a placebo yogurt containing polydextrose or the nutritionalintervention composition of the present invention in low fat yogurt.

[0090] Subjects received both formulations three days apart in acrossover double blind designed protocol. Following consumption of theyogurt containing either the placebo or the nutritional interventioncomposition of the present invention, subjects measured hunger andthirst sensations using a visual analog scale. Measurements were takenevery fifteen minutes for three and a half hours. The results showedthere was no difference in thirst sensation, however there was asignificant difference in hunger ratings. At 45 minutes subjectsreceiving a yogurt that contained the nutritional interventioncomposition of the present invention had significant less hunger andthis decreased hunger was extended for almost two hours and ten minutes.An analysis of variance showed a significant treatment effect with a pvalue less than 0.05. When subjects were asked to rate “how much foodthey could eat” over the duration of the test there was a significantdifference between subjects taking the placebo yogurt and subjectstaking yogurt containing the nutritional composition of the presentinvention. Subjects taking the nutritional intervention composition ofthe present invention had a significantly less desire to eat. Ananalysis of variance showed a significant treatment effect with a pvalue less than 0.05.

[0091] Experiment Three-Effect of the Nutritional InterventionComposition of the Present Invention on Weight Loss and Appetite OverSix Weeks

[0092] In an open trial 113 overweight subjects (Body Mass Index=27-32)between the ages of 22-55 were administered the nutrition composition ofthe present invention three times a day 15 minutes prior to theirbreakfast, lunch and dinner meals for a period of six weeks. Subjectswere asked to maintain a 1740 calorie per day diet and materials weregiven to them to assist in their meal planning.

[0093] Each week subjects were asked to fill out a questionnairemeasuring global satiety. They were asked whether they agreed ordisagreed with the following statements:

[0094] 1. I have experienced changes in my appetite.

[0095] 2. I crave food all the time.

[0096] 3. I have no appetite at all.

[0097] The results showed there was a mean weight loss of 8.82 lbs. Inaddition, the subjects experienced a significant change in mean satietyscores when their subjective feelings of hunger, fullness and appetitewere compared to the pre-study readings.

[0098] At the end of the study 49% of the respondents Agreed/StronglyAgreed with the statement “I have experienced changes in my appetite”compared to 28% prior to the study.

[0099] At the end of the study 11% of the respondents Agreed/StronglyAgreed with the statement “I crave food all the time” compared to 33%prior to the study.

[0100] At the end of the study 8% of the respondents Agreed/StronglyAgreed with the statement “I have no appetite at all” compared to 4%prior to the study.

[0101] Respondents who lost more than 5 lbs had a greater change in meansatiety ratings over the course of the study.

[0102] The results of this open trial show that the nutritionalcomposition of the present invention increased satiety and reducedhunger cravings in subjects that were on a calorically restricted diet.In addition the nutritional composition of the present inventionproduced a mean weight loss of 8.82 lbs.

ADVANTAGES OF THE PRESENT INVENTION

[0103] Accordingly an advantage of the present invention is that itprovides a nutrition intervention composition for enhancing satietybefore a meal.

[0104] Another advantage of the present invention is that it provides anutrition intervention composition to extend satiety after a meal.

[0105] Another advantage of the present invention is that it provides anutrition intervention composition that can be consumed prior to a mealto enhance satiety.

[0106] Another advantage of the present invention is to provide anutrition intervention composition that can be added to food to extendthe satiating effect of the food to which it is added.

[0107] Another advantage of the present invention is that it provides anutrition intervention composition that it stimulates cholecystokininrelease in a calorically efficient manner.

[0108] Another advantage of the present invention is that it provides anutrition intervention composition that increases cholecystokinin bystimulating its release through a combination of nutritional agents.

[0109] Another advantage of the present invention is that it provides anutrition intervention composition that blocks the inhibition ofcholecystokinin release by binding soluble and insoluble fibers to bilesalts.

[0110] Another advantage of the present invention is that it provides anutrition intervention composition to cause weight loss resulting from areduced caloric intake.

[0111] Another advantage of the present invention is that it provides anutrition intervention composition to provide better glycemic controlfor Type II diabetics.

[0112] Another advantage of the present invention is that it provides anutrition intervention composition to help Type II diabetics enhance andextend satiety in a calorically efficient fashion.

[0113] Another advantage of the present invention is that it provides anutrition intervention composition to increase satiety in bulimics whohave a defect in their normal CCK release mechanism.

[0114] Another advantage of the present invention is that it provides anutrition intervention composition to help in the management of thebulimic patients.

[0115] Another advantage of the present invention is that it provides anutrition intervention composition that is palatable, well tolerated andwithout side effects to individuals.

[0116] A latitude of modification, change, and substitution is intendedin the foregoing disclosure, and in some instances, some features of theinvention will be employed without a corresponding use of otherfeatures. Accordingly, it is appropriate that the appended claims beconstrued broadly and in a manner consistent with the spirit and scopeof the invention herein.

What is claimed is:
 1. A nutritional intervention composition takenbefore or during a meal for enhancing and extending post meal satiety bystimulating cholecystokinin (CCK) levels in a calorically efficientmanner for reducing weight, comprising: a) a protein selected from thegroup consisting of casein, whey and soy being in the range of 0.10 to10.0 grams by weight of said composition; b) a glycomacropeptide orcaseinmacropeptide being in the range of 0.025 to 10.00 grams by weightof said composition; c) at least one long chain fatty acid (C₁₂ to C₁₈)being in the range of 1.00 to 15.00 grams by weight of said composition;and d) at least one soluble fiber, or at least one insoluble fiber, or amixture thereof for binding bile salts being in the range of 0.20 to10.00 grams by weight of said composition.
 2. A nutritional interventioncomposition in accordance with claim 1 , wherein said at least onesoluble fiber is selected from the group consisting of guar,glucomannan, potato, methyl cellulose, phyllium and sugar beet.
 3. Anutritional intervention composition in accordance with claim 2 ,wherein said at least one soluble fiber is in the range of 0.10 to 5.00grams by weight of said composition.
 4. A nutritional interventioncomposition in accordance with claim 2 , wherein said at least onesoluble fiber is in the range of 1.0 to 4.0 grams by weight of saidcomposition.
 5. A nutritional intervention composition in accordancewith claim 1 , wherein said at least one insoluble fiber is selectedfrom the group consisting of cellulose and potato.
 6. A nutritionalintervention composition in accordance with claim 4 , wherein said atleast one insoluble fiber is in the range of 0.10 to 5.00 grams byweight of said composition.
 7. A nutritional intervention composition inaccordance with claim 4 , wherein said at least one insoluble fiber isin the range of 0.50 to 3.00 grams by weight of said composition.
 8. Anutritional intervention composition in accordance with claim 1 ,wherein said at least one long chain fatty acid (C₁₂ to C₁₈) is oleicacid.
 9. A nutritional intervention composition in accordance with claim8 , wherein said oleic acid is in the range of 1.0 to 4.0 grams byweight of said composition.
 10. A nutritional intervention compositionin accordance with claim 1 , further including bile acid sequesteringresins such as cholestyramine being in the range of 0.1 to 5.0 grams byweight of said composition.
 11. A nutritional intervention compositionin accordance with claim 1 , further including a flavoring componentbeing in the range of 1.10 to 3.0 grams by weight of said composition.12. A nutritional intervention composition in accordance with claim 1 ,further including an emulsifier.
 13. A nutritional interventioncomposition in accordance with claim 12 , wherein said emulsifier is inthe range of 0.20 to 0.40 grams by weight of said composition.
 14. Anutritional intervention composition in accordance with claim 12 ,wherein said emulsifier is lecithin.
 15. A nutritional interventioncomposition in accordance with claim 1 , further including plantsaponins.
 16. A nutritional intervention composition in accordance withclaim 15 , wherein said plant saponins are in the range of 0.05 to 10.0grams by weight of said composition.
 17. A nutritional interventioncomposition in accordance with claim 1 , further including a sweetenerin the range 0.015 to 4.0 grams by weight of said composition.
 18. Anutritional intervention composition in accordance with claim 1 ,further including calcium.
 19. A nutritional intervention composition inaccordance with claim l, wherein said composition has a caloric contentof 9.95 to 215 calories.
 20. A nutritional intervention composition inaccordance with claim 1 , wherein said composition is in the form of adry powder.
 21. A nutritional intervention composition in accordancewith claim 1 , wherein said composition is part of a liquid drink.
 22. Anutritional intervention composition in accordance with claim 1 ,wherein said composition is part of a bar.
 23. A nutritionalintervention composition in accordance with claim 1 , wherein saidcomposition is taken before a meal is consumed.
 24. A nutritionalintervention composition in accordance with claim 1 , wherein saidcomposition is taken during the consumption of a meal.
 25. A nutritionalintervention composition in accordance with claim 1 , wherein saidcomposition is a food additive to other foods.
 26. A nutritionalcomposition in accordance with claim 25 , wherein said food additive isadded to foods selected from the group consisting of yogurt, jello,apple sauce, cottage cheese, cereal, bread, and candy bars.
 27. Anutritional composition in accordance with claim 25 , wherein said foodadditive is added to drinks selected from the group consisting of applejuice, orange juice, grape juice, grapefruit juice, cranberry juice,coffee, tea, milk, milkshakes, broth, and soup consomme.
 28. Anutritional composition in accordance with claim 1 , wherein the totalweight of said composition is the range of 1.425 grams to 58.00 grams.29. A nutritional intervention composition taken before or during a mealfor enhancing and extending post meal satiety by stimulatingcholecystokinin (CCK) levels in a calorically efficient manner forreducing weight, comprising: a) a protein selected from the groupconsisting of casein, whey and soy being in the range of 0.21% to 88.30%by weight of said composition; b) a glycomacropeptide orcaseinmacropeptide being in the range of 0.05% to 87.72% by weight ofsaid composition; c) at least one long chain fatty acid (C₁₂ to C₁₈)being in the range of 2.27% to 97.25% by weight of said composition; andd) at least one soluble fiber, or at least one insoluble fiber, or amixture thereof for binding bile salts being in the range of 0.41% to89.09% by weight of said composition.
 30. A nutritional interventioncomposition in accordance with claim 29 , wherein said at least onesoluble fiber is selected from the group consisting of guar,glucomannan, potato, methyl cellulose, phyllium and sugar beet.
 31. Anutritional intervention composition in accordance with claim 29 ,wherein said at least one insoluble fiber is selected from the groupconsisting of cellulose and potato.
 32. A nutritional interventioncomposition in accordance with claim 29 , wherein said at least one longchain fatty acid (C₁₂ to C₁₈) is oleic acid.
 33. A nutritionalintervention composition in accordance with claim 32 , wherein saidoleic acid is in the range of 2.27% to 97.25% by weight of saidcomposition.
 34. A nutritional intervention composition in accordancewith claim 29 , further including cholestyramine.
 35. A nutritionalintervention composition in accordance with claim 34 , further includinga flavoring component being in the range of 3.73% to 34.11%.
 36. Anutritional intervention composition in accordance with claim 29 ,further including an emulsifier.
 37. A nutritional interventioncomposition in accordance with claim 36 , wherein said emulsifier is inthe range of 0.65% to 6.56% by weight of said composition.
 38. Anutritional intervention composition in accordance with claim 36 ,wherein said emulsifier is lecithin.
 39. A nutritional interventioncomposition in accordance with claim 29 , further including plantsaponins.
 40. A nutritional intervention composition in accordance withclaim 29 , further including a sweetener.
 41. A nutritional interventioncomposition in accordance with claim 40 , wherein said sweetener is inthe range of 0.05% to 40.49% by weight of said composition.
 42. Anutritional intervention composition in accordance with claim 29 ,further including calcium.
 43. A nutritional intervention composition inaccordance with claim 29 , wherein said composition has a caloriccontent of 9.95 to 215 calories.
 44. A nutritional interventioncomposition in accordance with claim 29 , wherein said composition is inthe form of a dry powder.
 45. A nutritional intervention composition inaccordance with claim 29 , wherein said composition is part of a liquiddrink.
 46. A nutritional intervention composition in accordance withclaim 29 , wherein said composition is part of a bar.
 47. A nutritionalintervention composition in accordance with claim 29 , wherein saidcomposition is taken before a meal is consumed.
 48. A nutritionalintervention composition in accordance with claim 29 , wherein saidcomposition is taken during the consumption of a meal.
 49. A nutritionalintervention composition in accordance with claim 29 , wherein saidcomposition is a food additive to other foods.
 50. A nutritionalintervention composition in accordance with claim 49 , wherein said foodadditive is added to foods selected from the group consisting of yogurt,jello, apple sauce, cottage cheese, cereal, bread, and candy bars.
 51. Anutritional intervention composition in accordance with claim 49 ,wherein said food additive is added to drinks selected from the groupconsisting of apple juice, orange juice, grape juice, grapefruitjuice,cranberryjuice, coffee, tea, milk, milkshakes, broth, and soup consomme.52. A nutritional intervention composition in accordance with claim 29 ,wherein the total weight of said composition is in the range of 1.425grams to 58.00 grams.
 53. A nutritional intervention composition takenbefore or during a meal for enhancing and extending post meal satiety bystimulating cholecystokinin (CCK) levels in a calorically efficientmanner for reducing weight, comprising: a) a glycomacropeptide orcaseinmacropeptide being in the range of 0.025 to 10.0 grams by weightof said composition; b) at least one long chain fatty acid (C₁₂ to C₁₈)being in the range of 1.00 to 15.0 grams by weight of said composition;and c) at least one soluble fiber, or at least one insoluble fiber, or amixture thereof for binding bile salts being in the range of 0.20 to10.00 grams by weight of said composition.
 54. A nutritionalintervention composition in accordance with claim 53 , wherein said atleast one soluble fiber is selected from the group consisting of guar,glucomannan, potato, methyl cellulose, phyllum and sugar beet.
 55. Anutritional intervention composition in accordance with claim 54 ,wherein said at least one soluble fiber is in the range of 0.10 to 5.00grams by weight of said composition.
 56. A nutritional interventioncomposition in accordance with claim 54 , wherein said at least onesoluble fiber is in the range of 1.0 to 4.0 grams by weight of saidcomposition.
 57. A nutritional intervention composition in accordancewith claim 53 , wherein said at least one insoluble fiber is selectedfrom the group consisting of cellulose and potato.
 58. A nutritionalintervention composition in accordance with claim 57 , wherein said atleast one insoluble fiber is in the range of 0.10 to 5.00 grams byweight of said composition.
 59. A nutritional intervention compositionin accordance with claim 57 , wherein said at least one insoluble fiberis in the range of 0.50 to 3.00 grams by weight of said composition. 60.A nutritional intervention composition in accordance with claim 53 ,wherein said at least one long chain fatty acid (C₁₂ to C₁₈) is oleicacid.
 61. A nutritional intervention composition in accordance withclaim 60 , wherein said oleic acid is in the range of 1.0 to 4.0 gramsby weight of said composition.
 62. A nutritional interventioncomposition in accordance with claim 53 , further includingcholestyramine being in the range of 0.1 to 5.0 grams by weight of saidcomposition.
 63. A nutritional intervention composition in accordancewith claim 53 , further including a flavoring component being in therange of 1.10 to 3.0 grams by weight of said composition.
 64. Anutritional intervention composition in accordance with claim 53 ,further including an emulsifier.
 65. A nutritional interventioncomposition in accordance with claim 64 , wherein said emulsifier is inthe range of 0.20 to 0.40 grams by weight of said composition.
 66. Anutritional intervention composition in accordance with claim 64 ,wherein said emulsifier is lecithin.
 67. A nutritional interventioncomposition in accordance with claim 53 , further including plantsaponins.
 68. A nutritional intervention composition in accordance withclaim 67 , wherein said plant saponins are in the range of 0.05 to 10.0grams by weight of said composition.
 69. A nutritional interventioncomposition in accordance with claim 53 , further including a sweetenerbeing in the range of 0.015 to 4.0 grams by weight of said composition.70. A nutritional intervention composition in accordance with claim 53 ,further including calcium.
 71. A nutritional intervention composition inaccordance with claim 53 , wherein said composition has a caloriccontent of 9.95 to 175 calories.
 72. A nutritional interventioncomposition in accordance with claim 53 , wherein said composition is inthe form of a dry powder.
 73. A nutritional intervention composition inaccordance with claim 53 , wherein said composition is part of a liquiddrink.
 74. A nutritional intervention composition in accordance withclaim 53 , wherein said composition is part of a bar.
 75. A nutritionalintervention composition in accordance with claim 53 , wherein saidcomposition is taken before a meal is consumed.
 76. A nutritionalintervention composition in accordance with claim 53 , wherein saidcomposition is taken during the consumption of a meal.
 77. A nutritionalintervention composition in accordance with claim 53 , wherein saidcomposition is a food additive to other foods.
 78. A nutritionalcomposition in accordance with claim 77 , wherein said food additive isadded to foods selected from the group consisting of yogurt, jello,apple sauce, cottage cheese, cereal, bread, and candy bars.
 79. Anutritional composition in accordance with claim 77 , wherein said foodadditive is added to drinks selected from the group consisting of applejuice, orange juice, grape juice, grapefruit juice, cranberry juice,coffee, tea, milk, milkshakes, broth, and soup consomme.
 80. Anutritional composition in accordance with claim 53 , further includinga protein selected from the group consisting of casein, whey and soybeing in the range of 0.10 grams to 10.0 grams by weight of saidcomposition.
 81. A nutritional composition in accordance with claim 53 ,wherein the total weight of said composition is the range of 1.225 gramsto 24.00 grams.
 82. A nutritional intervention composition taken beforeor during a meal for enhancing and extending post meal satiety bystimulating cholecystokinin (CCK) levels in a calorically efficientmanner for reducing weight, comprising: a) a glycomacropeptide orcaseinmacropeptide being in the range of 0.18% to 89.29% by weight ofsaid composition; b) at least one long chain fatty acid (C₁₂ to C₁₈)being in the range of 4.76% to 94.67% by weight of said composition; andc) at least one soluble fiber, or at least one insoluble fiber, or amixture thereof for binding bile salts being in the range of 1.41% to90.70% by weight of said composition.
 83. A nutritional interventioncomposition in accordance with claim 82 , wherein said at least onesoluble fiber is selected from the group consisting of guar,glucomannan, potato and sugar beet.
 84. A nutritional interventioncomposition in accordance with claim 82 , wherein said at least oneinsoluble fiber is selected from the group consisting of cellulose andpotato.
 85. A nutritional intervention composition in accordance withclaim 82 , wherein said at least one long chain fatty acids (C₁₂ to C₁₈)is oleic acid.
 86. A nutritional intervention composition in accordancewith claim 85 , wherein said oleic acid is in the range of 4.76% to94.67% by weight of said composition.
 87. A nutritional interventioncomposition in accordance with claim 82 , further including a flavoringcomponent.
 88. A nutritional intervention composition in accordance withclaim 82 , further including an emulsifier.
 89. A nutritionalintervention composition in accordance with claim 82 , further includingplant saponins.
 90. A nutritional intervention composition in accordancewith claim 82 , further including a cholestyramine.
 91. A nutritionalintervention composition in accordance with claim 82 , further includinga sweetener.
 92. A nutritional intervention composition in accordancewith claim 82 , further including calcium.
 93. A nutritionalintervention composition in accordance with claim 82 , wherein saidcomposition has a caloric content of 9.55 to 175 calories.
 94. Anutritional intervention composition in accordance with claim 82 ,wherein said composition is in the form of a dry powder.
 95. Anutritional intervention composition in accordance with claim 82 ,wherein said composition is part of a liquid drink.
 96. A nutritionalintervention composition in accordance with claim 82 , wherein saidcomposition is part of a bar.
 97. A nutritional intervention compositionin accordance with claim 82 , wherein said composition is taken before ameal is consumed.
 98. A nutritional intervention composition inaccordance with claim 82 , wherein said composition is taken during theconsumption of a meal.
 99. A nutritional intervention composition inaccordance with claim 82 , wherein said composition is a food additiveto other foods.
 100. A nutritional intervention composition inaccordance with claim 99 , wherein said food additive is added to foodsselected from the group consisting of yogurt, jello, apple sauce,cottage cheese, cereal, bread, and candy bars.
 101. A nutritionalintervention composition in accordance with claim 99 , wherein said foodadditive is added to drinks selected from the group consisting ofapplejuice, orange juice, grape juice, grapefruit juice, cranberryjuice, coffee, tea, milk, milkshakes, broth, and soup consomme.
 102. Anutritional intervention composition in accordance with claim 82 ,wherein the total weight of said composition is in the range of 1.225grams to 24.00 grams.
 103. A nutritional composition in accordance withclaim 82 , further including a protein selected from the groupconsisting of casein, whey and soy.